Teclistamab in Previously Treated AL Amyloidosis

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Enrolling

Phase 2

Conditions

AL Amyloidosis

Treatments

Drug: Teclistamab (Tec)

Study type

Interventional

Funder types

Other

Identifiers

NCT06935162

Tec-001

Details and patient eligibility

About

This is a phase II study in patients with previously treated immunoglobulin light-chain (AL) Amyloidosis to evaluate the efficacy and safety of teclistamab

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Biopsy confirmed AL amyloidosis
Patients must have received at least one line of treatment, including daratumumab and bortezomib
Relapse from previous treatment, or less than partial response after two cycles of treatment/less than very good partial response after three cycles of treatment
dFLC > 50mg/L

Exclusion criteria

Previous anti-BCMA targeted therapy
Co-morbidity of uncontrolled infection
Co-morbidity of other active malignancy
Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia
Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those with implanted pacemaker)
Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia
Seropositive for human immunodeficiency virus
Hepatitis B virus (HBV)-DNA > 1000 copies/mL
Seropositive for hepatitis C (except in the setting of a sustained virologic response)
Neutrophil <1×10E9/L, hemoglobin < 8g/dL, or platelet < 75×10E9/L.
Severely compromised hepatic or renal function: alanine transaminase (ALT) or aspertate aminotransferase (AST) > 5 × upper limit of normal (ULN), total bilirubin > 2 × ULN, eGFR < 20 mL/min, or receiving renal replacement therapy